- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01933555
Impact of Women's Empowerment Program for Abused Pregnant Women
August 28, 2013 updated by: Macmillan Research Group UK
Impact of Women's Empowerment Program for Abused Pregnant Women: A Randomized Controlled Trial
Although domestic violence is recognized as major threat in pregnancy, there is no intervention has been developed or test to support women in India.
To evaluate the effect of women's empowerment program administered to abused women in order to reduce domestic abuse, improving health status and safety behavior.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
76
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rajasthan
-
Jaipur, Rajasthan, India, 302019
- NMP Medical Research Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- at least 18 years of age,
- victims of intimate partner violence, and
- willing to participate
Exclusion Criteria:
- women whose abuser was not their intimate partner or
- who were unable to consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Empowerment program
The hour intervention, delivered over a 11-week period, consisted of an empowerment and additional components adapted from Freedom program run to support domestic abused women.
|
|
|
No Intervention: Control group
Standard care, which was routine check ups and care provided by health care professionals.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Quality of life(Sf-36)
Time Frame: Five Months
|
Five Months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Post natal depression
Time Frame: 5 months
|
5 months
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Domestic Violence Inventory and safety seeking behavior
Time Frame: 5 months
|
5 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Neha Sharma, PhD, Macmillan research group
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
August 1, 2013
Study Registration Dates
First Submitted
August 28, 2013
First Submitted That Met QC Criteria
August 28, 2013
First Posted (Estimate)
September 2, 2013
Study Record Updates
Last Update Posted (Estimate)
September 2, 2013
Last Update Submitted That Met QC Criteria
August 28, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- Mac/NMP 0912
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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